跳至主要内容
临床试验/NCT04530851
NCT04530851已完成不适用

Compare Outcome of Enhanced Recovery After Cesarean Surgery and Conventional Care in Rajavithi Hospital

Rajavithi Hospital2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2020年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
2
主要终点
Compare length of stay of pregnant women after Cesarean section between ERAS protocol and conventional care

研究概览

简要总结

Research objective to compare outcome(Length of stay, pain score, opioid drug use, Bowel function and complication ) of ERAS protocol and conventional care in pregnant women after elective cesarean section in Rajavithi hospital.

详细描述

Research design is Randomized control trial. The pregnant women who go to elective cesarean section don't know the allocation. The group of ERAS protocol was separated from Conventional care in patient care unit.

The Pregnant are randomly in two group. In the ERAS group the pregnant receive the the intervention for preoperative care(Counselin, H2- antagonist and metroclopramide for prevent aspiration, Drink clear liquid until 2 hour before surgery), Intraoperative care (first generation cephalosporin in 60 minute before surgery, Clorhexidine for skin cleansing and Povidine for vaginal cleansing, regional anesthesia, keep warming, blunt expansion of uterine incision, do not peritoneal suture and subcuticular suture if less than 2 cm, local wound anesthesia.), post operative care ( Paracetamol and NSAIDs for for pain control, early remove catheter and ambulation, 5-HT3 antagonist for prevent nausea)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women who scheduled for elective Cesarean section at Rajavithi Hospital

排除标准

  • Pregnant women who has preeclampsia with severe feature
  • Pregnant women who has diabetes mellitus with uncontrolled blood sugar
  • Pregnant women who has blood loss > 1,500 ml after surgery
  • Pregnant women who has chrioamnionitis.
  • Pregnant women who has severe medical disease
  • Pregnant women who has BMI >= 40 kg/m2
  • Pregnant women who has placenta adherence.

结局指标

主要结局

Compare length of stay of pregnant women after Cesarean section between ERAS protocol and conventional care

时间窗: 1 year

The primary outcome is length of stay (Day)

次要结局

  • Compare pain of pregnant women after Cesarean section between ERAS protocol and conventional care(1 year)
  • Compare opioid use of pregnant women after Cesarean section between ERAS protocol and conventional care(1 year)
  • Compare complication of pregnant women after Cesarean section between ERAS protocol and conventional care(1 year)
  • Compare bowel function of pregnant women after Cesarean section between ERAS protocol and conventional care(1 year)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验